Automatic-locking safety needle covers and methods of use and manufacture

ABSTRACT

A single-use needle cover configured to obscure, protect, or hide at least a portion of a needle from view before, during, and/or after an injection and/or aspiration procedure is disclosed. In some embodiments, the cover includes a housing at least partially containing the needle and configured to couple to a syringe, wherein the housing includes an axis and a guide member. In some embodiments, a sleeve has a plurality of tracks configured to slidingly receive the guide member, wherein the sleeve is configured to retract, extend, and rotate with respect to the housing. In some embodiments, after the sleeve has been retracted and extended one time, a first locking member inhibits further retraction of the sleeve and a second locking member inhibits rotation of the sleeve.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/822,106, filed Jun. 23, 2010, titled “AUTOMATIC-LOCKING SAFETY NEEDLECOVERS AND METHODS OF USE AND MANUFACTURE,” the entirety of which isincorporated herein by reference.

BACKGROUND

Certain embodiments disclosed herein relate to needle covers and needlecover assemblies for medical devices, such as syringes, and areparticularly related to obscuring at least a portion of the needle fromview and aiding in the transfer of fluids.

DESCRIPTION OF THE RELATED ART

Syringes are used throughout the medical industry for the injection andwithdrawal of a wide variety of fluids and solutions into and from thehuman body. Due to the numerous potential hazards associated with thehandling and manipulation of bodily fluids, and particularly blood,there are a number of known safety features that are frequentlyincorporated into various types of syringes and syringe needles. Forexample, many syringe needles are provided with a removable cap thatgenerally prevents needle sticks while the cover is in place. When thecap is removed, the needle is exposed. These caps are removed before aninjection and/or aspiration procedure and replaced after the injectionand/or aspiration procedure before discarding the needle. Among otherconcerns, this removal and replacement procedure creates a risk ofaccidental needle sticks.

Syringes and syringe needles are frequently configured such that atleast the needles are disposable; that is, they are intended to be usedonly once and then thrown away. This procedure reduces the likelihood oftransferring blood or tissue-born diseases from one patient to another.To this end, many syringe needles are configured to be quickly andeasily detached from an appropriately configured syringe body. In thisway, the syringe body may be reusable, and made of a relatively durablematerial, such as metal, while the disposable needle assemblies may bemade of plastic or other similar, relatively inexpensive, materials.

SUMMARY

Several variations and combinations of needle covers are disclosed. Incertain embodiments a single-use needle cover comprises a housingconfigured to couple to a syringe and at least partly (or completely)contain or shield from view the needle, wherein the housing includes aguide member, a first locking member, and a second locking member; asleeve configured to move or telescope between an extended position anda retracted position with respect to the housing, wherein the extendedposition generally covers a distal tip of the needle and the retractedposition exposes at least a portion of the distal tip of the needle, andwherein the sleeve is biased toward the extended position. In someembodiments, the movement or telescoping of the sleeve from the extendedposition to the retracted position rotates the sleeve with respect tothe housing, transfers the guide member from a first track to a secondtrack included in the sleeve, and engages a first locking member;wherein movement or telescoping of the sleeve from the retractedposition to the extended position engages a second locking member; andwherein the first and second locking members inhibit movement ortelescoping of the cover to prevent reuse. In some arrangements, thefirst locking member comprises a rib on the housing. In someembodiments, the second locking member comprises a radially inwardlyextending arm on the housing. In some embodiments, the sleeve furtherincludes a flange, which engages the first and second locking members.In some arrangements, the first locking member comprises a rib on thehousing, the second locking member comprises a radially inwardlyextending arm on the housing, and the sleeve further includes a flangethat engages the first and second locking members. In some embodiments,the sleeve includes a third track intersecting the first and secondtracks. The third track can intersect the first track proximal to theintersection of the third track and the second track.

According to certain arrangements, a single-use needle cover cancomprise: a housing at least partially containing the needle andconfigured to couple to a syringe, wherein the housing includes an axisand a guide member; a sleeve configured to receive a distal tip of theneedle and to translate between a first position and a second position,wherein the sleeve rotates with respect to the housing during at leastsome of the translation, wherein the sleeve includes a plurality oftracks configured to receive the guide member; and wherein translationof the sleeve engages a first locking member configured to inhibit reuseof the needle cover. In some embodiments, the first position covers thedistal tip of the needle and the second position exposes the distal tipof the needle. In the cover, the first locking member can inhibit reuseof the needle cover by inhibiting translation of the sleeve. Thetranslation of the sleeve can also engage a second locking memberconfigured to inhibit reuse of the needle cover. The second lockingmember can inhibit reuse of the needle cover by inhibiting rotation ofthe sleeve. In some embodiments, the first locking member is an armcoupled to the housing and the second locking member is a rib coupled tothe housing. A spring can bias the sleeve toward the first position. Insome embodiments, the sleeve can translate from the first position tothe second position substantially without impediment. The sleeve caninclude a flange configured to engage the first locking member. Theflange can be further configured to engage a second locking member. Thefirst locking member can be engaged as the sleeve translates from thefirst position to the second position. A second locking member can beengaged as the sleeve translates from the second position to the firstposition.

According to certain embodiments a method of manufacturing a single-useneedle cover can comprise: forming a housing, wherein the housing atleast partially contains the needle is and configured to couple to asyringe, wherein the housing includes an axis and a guide member;forming a sleeve, wherein the sleeve is configured to receive a distaltip of the needle and to translate between a first position and a secondposition, wherein the sleeve rotates with respect to the housing duringat least some of the translation, wherein the sleeve includes aplurality of tracks configured to receive the guide member; and whereintranslation of the sleeve engages a first locking member configured toinhibit reuse of the needle cover. In some methods, the first positioncan cover the distal tip of the needle and the second position canexpose the distal tip of the needle. The first locking member caninhibit reuse of the needle cover by inhibiting translation of thesleeve. The translation of the sleeve can also engage a second lockingmember configured to inhibit reuse of the needle cover. The secondlocking member can inhibit reuse of the needle cover by inhibitingrotation of the sleeve.

In certain arrangements, a method of protecting against unintentionalneedle sticks with a needle cover can comprise: forming a housing,wherein the housing at least partially contains the needle is andconfigured to couple to a syringe, wherein the housing includes an axisand a guide member; forming a sleeve, wherein the sleeve includes aplurality of tracks configured to receive the guide member, wherein thesleeve is configured to receive a distal tip of the needle and to movebetween a first position and a second position, wherein the firstposition covers the distal tip of the needle and the second positionexposes the distal tip of the needle, and wherein the sleeve rotateswith respect to the housing during at least some of the movement; andwherein movement of the sleeve engages a first locking member configuredto inhibit further movement of the sleeve. In some embodiments, thefirst locking member inhibits reuse of the needle cover by inhibitingrotation of the sleeve. In some embodiments the first locking memberinhibits reuse of the needle cover by axial movement of the sleeve. Themovement of the sleeve can further engage a second locking memberconfigured to inhibit reuse of the needle cover. In some embodiments,the second locking member inhibits reuse of the needle cover byinhibiting axial movement of the sleeve. In some embodiments, the secondlocking member inhibits reuse of the needle cover by inhibiting rotationof the sleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an embodiment of a needlecover.

FIG. 1A illustrates a cross-sectional view of the embodiment of FIG. 1along the line 1A-1A in a ready for use, fully extended and unlocked,first position.

FIG. 1B illustrates a cross-sectional view along the line 1B-1B.

FIG. 1C illustrates a perspective view of the embodiment of FIG. 1 witha removable cap in the closed position.

FIG. 1D illustrates a perspective view of the embodiment of FIG. 1 witha removable cap in the open position.

FIG. 2 illustrates a perspective view of the embodiment of FIG. 1 in a,partially retracted, second position.

FIG. 2A illustrates a cross-sectional view along the line 2A-2A.

FIG. 2B illustrates a cross-sectional view along the line 2B-2B.

FIG. 3 illustrates a perspective view of the embodiment of FIG. 1 in a,partially retracted, third position, in which a flange has engaged arotational locking member.

FIG. 3A illustrates a cross-sectional view along the line 3A-3A.

FIG. 3B illustrates a cross-sectional view along the line 3B-3B.

FIG. 4 illustrates a perspective view of the embodiment of FIG. 1 in a,partially retracted, fourth position, in which the rotational lockingmember has been locked.

FIG. 4A illustrates a cross-sectional view along the line 4A-4A.

FIG. 4B illustrates a cross-sectional view along the line 4B-4B.

FIG. 5 illustrates a perspective view of the embodiment of FIG. 1 in a,fully retracted, fifth position.

FIG. 5A illustrates a cross-sectional view along the line 5A-5A.

FIG. 6 illustrates a perspective view of the embodiment of FIG. 1 in apartially extended sixth position, in which the flange has engaged anaxially locking member.

FIG. 6A illustrates a cross-sectional view along the line 6A-6A.

FIG. 7 illustrates a perspective view of the embodiment of FIG. 1 in apartially extended seventh position, in which the flange has furtherengaged the at least one axial locking member.

FIG. 7A illustrates a cross-sectional view along the line 7A-7A.

FIG. 8 illustrates a perspective view of the embodiment of FIG. 1 in afully extended reuse-prevented, eighth position.

FIG. 8A illustrates a cross-sectional view along the line 8A-8A.

FIG. 9 illustrates a perspective view of another embodiment of a needlecover.

FIG. 9A illustrates a cross-sectional view along the line 9A-9A in aready for use, fully extended and unlocked, position.

FIG. 9B illustrates a cross-sectional view along the line 9B-9B.

FIG. 10 illustrates a perspective view of the embodiment of FIG. 9 in apartially retracted position.

FIG. 10A illustrates a cross-sectional view along the line 10A-10A.

FIG. 10B illustrates a cross-sectional view along the line 10B-10B.

FIG. 11 illustrates a perspective view of the embodiment of FIG. 9 in afully retracted second position.

FIG. 11A illustrates a cross-sectional view along the line 11A-11A.

FIG. 11B illustrates a cross-sectional view along the line 11B-11B.

FIG. 12 illustrates a perspective view of the embodiment of FIG. 9 in afirst partially extended position.

FIG. 12A illustrates a cross-sectional view along the line 12A-12A.

FIG. 12B illustrates a cross-sectional view along the line 12B-12B.

FIG. 13 illustrates a perspective view of the embodiment of FIG. 9 in asecond partially extended position.

FIG. 13A illustrates a cross-sectional view along the line 13A-13A.

FIG. 13B illustrates a cross-sectional view along the line 13B-13B.

FIG. 14 illustrates a perspective view of the embodiment of FIG. 9 in afully-extended, reuse-prevented, position.

FIG. 14A illustrates a cross-sectional view along the line 14A-14A.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

A variety of examples of needle covers are described below to illustratevarious examples that may be employed to achieve the desiredimprovements. These examples are only illustrative and not intended inany way to restrict the general inventions presented and the variousaspects and features of these inventions. For example, althoughembodiments and examples are provided herein in the medical field, theinventions are not confined exclusively to the medical field and certainembodiments can be used in other fields. Furthermore, the phraseologyand terminology used herein is for the purpose of description and shouldnot be regarded as limiting. No features, structure, or step disclosedherein is essential or indispensible.

FIG. 1 illustrates a needle cover 10 that may be removably coupled to astandard or specially configured syringe (not shown). The cover 10includes features and components, discussed below in detail, thatgenerally obscure, protect, or hide at least a portion of (orsubstantially all of) a needle 16 from view before, during, and/or afteran injection and/or aspiration procedure, thereby reducing oralleviating at least some anxiety or fear that might otherwise be feltby certain patients or other individuals upon seeing the needle 16. Insome embodiments, all or nearly all of the needle is obscured, hidden,or protected by the cover 10. The cover 10 can also include features andcomponents that permit a fluid transfer procedure to be performed beforean injection and/or aspiration procedure without automaticallypreventing further use, but that automatically prevent the cover 10 andthe associated needle 16 from being used more than once to perform aninjection and/or aspiration procedure. As used herein, the terms“automatically,” and “automatic,” and similar terms, are intended tohave their ordinary meanings in the field. In some embodiments, as thecontext reflects, these terms refer to a mechanism or process thatoccurs in normal usage of a product, or that occurs while the user isperforming another process, without requiring an additional step ormanipulation by the user to achieve the desired result. Although theillustrated cover 10 is configured to be coupled to and removed from asyringe, the cover 10 may instead be integrally formed with the syringeor connected, either removably or permanently, to another medicalimplement. In either case, the syringe is generally of a known typesuitable for the withdrawal and injection and/or aspiration of fluids orother solutions by way of the cover 10. The locking system and/orreuse-inhibition features of the cover 10 could be used with manydifferent types of medical and non-medical products.

In the illustrated construction of FIGS. 1 and 1A, the cover 10 includesa generally cylindrical housing 14 that includes an axis 18, along whichthe needle 16 is positioned. A distal end of the housing 14 couples to asleeve 12 configured to move along and at least partially rotate aboutthe axis 18. As used herein, “proximal,” or any derivative thereof,refers to a direction toward the end of the cover 10 that connects to amedical device, e.g. a syringe; “distal,” or any derivatives thereof,refers to a direction toward the end of the cover 10 that contacts thesurface to be penetrated with the needle 16, e.g. a patient's skin. Achannel 26 and an aperture 28 are included in the sleeve 12 in order topermit the needle 16 to pass therethrough.

In some embodiments, a proximal end 34 of the housing 14 can comprise ahub 20 that can be configured for either removable or permanentattachment to the syringe, or that may be integrally formed with thesyringe. For example, the hub 20 may include internal or externalthreads or other suitable coupling, latching, or locking features suchas tabs, slots, projections, pressure/snap fits, and the like, which maybe provided in various combinations on various portions of the hub 20for coupling to the syringe. The coupling features can engagecorresponding features provided on the syringe to removably couple thecover 10 to the syringe. In some embodiments, the hub 20 may bepermanently fixed (e.g. by sonic welding, adhesive, pressure/snap fit,or the like) or integrally formed with the syringe. In some embodiments,the housing 14 includes a generally cylindrically reduced needle supportportion 30 that extends axially from the hub 20 and supports the needle16. As shown, the housing 14 and/or hub 20 are in fluid communicationwith the needle 16, thus permitting fluid to pass between the syringeand the needle 16.

The inside surface 22 of the housing 14 can include a central chamber36. A distal end 38 of the housing 14 can include a radially inwardlyextending shoulder 40 that includes an opening 42 that communicates withthe chamber 36. The opening 42 slidingly receives the sleeve 12 that inturn receives and at least partially covers the needle 16, as will bediscussed in further detail below. A guide member 44 extends radiallyinwardly from the shoulder 40 and is configured to engage one or moretracks formed in the sleeve 12. The outer surface 24 of the housing 14can include an outer portion 46 that is textured, knurled, or the liketo facilitate grasping the cover 10.

As shown in FIGS. 1 and 1A, the housing 14 can include at least oneaxial locking member 50. In some embodiments the axial locking member 50is positioned at least partially within an opening 48 included in thehousing 14. As shown, a first end 52 of the axial locking member 50 canbe coupled to the housing 14, while the second end 54 of the axiallocking member 50 can be disposed radially inward compared to the innersurface 22. In some embodiments, the axial locking member 50 isgenerally resilient, so that the radially inwardly disposed second ends54 can flex and then return to the original position even after the ends54 have been radially outwardly deflected. In some embodiments, thefirst end 52 is larger than the second end 54, e.g. the axial lockingmember 50 can taper from the first end 50 to the second end 54. In someembodiments, the axial locking member 50 includes a latching member,such as a hook, clasp, detent, ratchet, or other structure.

In the illustrated arrangement the housing 14 is of unitaryconstruction. This can be advantageous in that it reduces the totalnumber of components to be assembled to form the cover 10. In someembodiments, the housing 14 is formed from a plurality of components.For example, a proximal portion and a distal portion of the housing 14can be separate components that are joined using techniques, such as butnot limited to sonic welding, adhesive, snap or press fitting, or thelike.

With regard to FIG. 1A, the illustrated sleeve 12 includes a proximalend 60 positioned within the chamber 36 and a distal end 62 generallycovering the distal tip 96 of the needle 16. The proximal end 60includes a radially outwardly extending flange 64 that seats against theshoulder 40 of the distal end 38. As shown, the proximal end 60 can alsoinclude a substantially annular and axially extending locating portion66 that locates a biasing member in the form of a spring 70. In someembodiments the inner surface 22 of the proximal end 34 of the housing14 includes a similar portion 68 for locating the spring 70. The sleeve12 can include a collapsible portion.

In the illustrated embodiment, the spring 70 engages and extends betweenthe proximal end 60 of the sleeve 12 and the proximal end 34 of thehousing 14. The spring 70 biases the sleeve 12 toward an extendedposition in which the flange 64 of the sleeve 12 is biased intoengagement with the shoulder 40 of the distal end of the housing 38, andthe sleeve 12 completely covers the distal tip 96 of the needle 16. Manytypes of springs may be employed, such as but not limited to a helicalcoil spring, conical spring, wave-spring, Belleville washer, or thelike. In some embodiments, the spring 70 is a helical coil spring havinga free length of about 25 mm and a spring rate of about 0.12 N/mmthrough the linear portion of the spring's deflection. Otherconstructions may include softer or stiffer springs depending on theapplication, and may be constructed of substantially any suitablematerial. In some embodiments, the spring 70 is configured to facilitateretraction of the sleeve 12 by a user applying distal pressure to thesyringe and/or the cover 10 with just one hand. Progressive springsand/or multiple springs of varying lengths may also be used to provide avariable effective spring rate during movement of the sleeve 12 betweenfully extended and fully retracted positions.

The channel 26 can extend through the sleeve 12 and include a proximalportion 90, a tapered portion 92, and a distal portion 94. The proximalportion 90 can be configured to receive the needle support portion 30 ofthe housing 14 as the sleeve 12 is retracted. For example, in someembodiments the needle support portion 30 has a diameter of at leastabout 0.5 mm and/or less than or equal to about 5 mm and an axial lengthof at least about 2 mm and/or less than or equal to about 2.5 mm and theproximal portion 90 of the channel 26 has a diameter of at least about0.6 mm, and/or less than or equal to about 6 mm and an axial length ofat least about 2.5 mm and/or less than or equal to about 26 mm. In someembodiments, the diameter of the proximal portion 90 is larger than thediameter of the distal portion 92. In the arrangement shown, the taperedportion 92 transitions between the proximal and distal channel portions90, 94. The tapered portion 92 can guide the needle 16 into the distalchannel 94. In the embodiment shown, the distal portion 94 of thechannel 26 has a diameter that is about the same as the outside diameterof the needle 16 in order to, for example, support the needle 16.

Turning now to FIG. 1B, the illustrated flange 64 includes an outwardlyextending portion 100 from which an impeding member 102, such as aresilient member, extends, e.g. circumferentially, radially, axially, acombination thereof, or the like. The end 104 of the impeding member 102shown is shaped as a radially outwardly extending wedge (such that theradial width of the impeding member 102 increases toward the end 104)that has an inclined face 106 and a generally flat face 108. Similarly,a generally wedge-shaped rotational locking member 110, e.g. an axialrib, extends radially inwardly from the inner surface 22 of the housing14 and includes an inclined face 112 and a generally flat face 114. Inthe variant shown, the inclined face 112 is configured to be in theopposite direction as the inclined face 106. Although the end 104 androtational locking member 110 shown are generally wedge-shaped, manyshapes can be used, such as but not limited to generally hemispherical,frustoconical, undulating or the like. In some embodiments, the axiallength of the rotational locking member 110 is greater than the axiallength of the impeding member 102 and/or the sleeve 64. In someembodiments, at least a portion of the impeding member 102 is configuredto fit into at least a portion of the rotational locking member 110 orvice versa. For example, the impeding member 102 can comprise a tabconfigured to fit within a slot included in the rotational lockingmember 110. In some embodiments, at least a portion of the impedingmember 102 is configured to fit into an opening in the housing 14. Anotch 116 separates the outwardly extending portion 100 and the end 104.The notch 116 can be configured to be at least as large as the axialcross-section of the axial locking member 50, as will be discussed infurther detail below.

Turning back to FIG. 1, the sleeve 12 includes a plurality of tracks80-84 to aid in, for example, directing the sleeve 12 during movement.In many arrangements, the tracks are configured to slidingly receive theguide member 44 of the housing 12. Accordingly, the tracks 80-84 can beconfigured to have a similar cross-sectional shape as the guide member44, e.g., generally rectangular, generally T-shaped, generally circularsector, or the like. For instance, the illustrated guide member 44 andthe tracks 80-84 are generally trapezoidal in cross sectional shape. Afirst track 80 and a second track 82 are generally parallel to the axis18 and extend along the sleeve 12 from the proximal end 60 to the distalend 62. A separation member 85 separates the tracks 80, 82 throughout atleast a portion of, or most of, their length. A separate transfer track84 can be positioned in a middle or intermediate region along the lengthof the sleeve and at angle relative to the axis 18 (e.g., non-parallelto the axis), and can interrupt the separation member 85 and intersectthe first and second tracks 80, 82. The transfer track 84 can thusconnect the first and second tracks 80, 82 to permit the guide member 44to shift between the first and second tracks 80, 82 as will be discussedin further detail below. The transfer track 84 can be generally straightand non-curvilinear to facilitate smooth travel along the transfer tack84. In the example illustrated, the intersection of the transfer track84 is positioned in about the middle of the sleeve 12, and theintersection of the transfer track 84 and the first track 80 is proximalto the intersection of the transfer track 84 and the second track 82. Insome embodiments, the length of the transfer track 84 can be generallyabout the same size as a cross-sectional width (e.g., a diameter) of thesleeve 12 and can be substantially smaller than the length of the sleeve12. In the illustrated embodiment, the transfer track 84 does notconstitute a portion of, or a continuation of, either of the first orsecond tracks 80, 82; rather, the transfer track 84 extends away fromboth other tracks 80, 82 at a point on each track 80, 82 that is spacedbetween the beginning and end of the tracks 80, 82 (e.g., at anintermediate or middle region of the tracks 80, 82).

In some embodiments the first track 80 includes an insertion portion 86distal to the transfer track 84. The insertion portion 86 can beconfigured to be inclined in the proximal direction and terminate in agenerally flat face 88 at the intersection between the first track 80and the transfer track 84. In certain embodiments, the insertion portion86 facilitates assembly of the cover 10. For example, during assembly ofone arrangement the sleeve 12 is inserted through the proximal end 34 ofthe housing 14 and moved distally. The distal end 62 of the sleeve 12 ispositioned so that the guide member 44 is generally aligned withinsertion portion 86 of the first track 80. As the sleeve is moveddistally the guide member 44 moves or rides up the incline of theinsertion portion 86 until reaching the generally flat face 88, at whichpoint the guide member 44 can snap to the bottom of the first track 80.Thereafter, the flat face 88 can inhibit or prevent disassembly of thecover 10 by presenting a barrier to the guide member 44 moving distallyalong the insertion portion 86. Further, the flat face 88 can direct theguide member 44 from the first track 80 to the transfer track 84 duringretraction of the sleeve 12.

The cover 10 can have many different sizes, to accommodate the varioussizes of needle and types of insertion and/or withdrawal procedures. Forexample, the cover 10 can be configured to accommodate needles used inmedical (including dentistry) and veterinary procedures. In someembodiments the cover 10 can have an overall length of at least about 10mm and/or less than or equal to about 100 mm, a housing 14 diameter ofat least about 6 mm and/or less than or equal to about 20 mm, and asleeve 12 diameter of at least about 3 mm and/or less than or equal toabout 18 mm. In some embodiments, the sleeve 12 is longer than thehousing 14; in some embodiments, the housing 14 is longer than thesleeve 12. Some examples of the cover 10 include a housing 14 with alength of about at least about 5 mm and/or equal to or less than about50 mm and a sleeve with a length of about at least about 5 mm and/orequal to or less than about 50 mm. Other arrangements have a housing 14with a length of at least about 15 mm and/or equal to or less than about30 mm and a sleeve with a length of about at least about 10 mm and/orless than or equal to about 40 mm. Some embodiments of the cover areconfigured for use with needles 16 having a gauge of at least about 7and/or less than or equal to about 34.

Many embodiments of the sleeve 12 and housing 14 are configured toprovide a variety of potential insertion depths (the maximum penetrationdistance by the needle 16). This can assist in addressing, for example,dissimilar desired insertion depths between various procedures, e.g.intramuscular versus subcutaneous injections. In some embodiments, thepotential insertion depth is determined by the distance the sleeve 12travels from the fully extended position (FIG. 1) to the fully retractedposition (FIG. 5). In some embodiments, the potential insertion depth isat least 1 mm and/or less than or equal to about 30 mm. In anotherconstruction, the potential insertion depth is at least 3 mm and/or lessthan or equal to about 70 mm. In some embodiments, there is a mechanismfor determining, setting, and/or varying the potential insertion depth.For example, some embodiments include a stop member (not shown)extending radially inwardly from the inner surface 22 of the housing 14and coupled to an axially movable ratchet, such that the proximal end 60of the sleeve 12 abuts against the stop member when a desired level ofinsertion depth is attained. In some embodiments, the cover 10 includesindicia, e.g. a scale printed on the sleeve 12, to indicate theinsertion depth of the needle 16.

The cover 10, and components thereof, can be formed using manymanufacturing processes sufficient to provide the desired shape of thecomponents. In some embodiments one or more components are made by amolding process, such as but not limited to injection molding,compression molding, blow molding, transfer molding, or similar. In someembodiments, one or more components are formed by forging, machining,casting, stamping, extrusion, a combination thereof, or the like.

In many embodiments, the cover 10 is constructed from a biocompatiblematerial. In some arrangements one or more of the components of thecover 10 are plastic (e.g. polyetheretherketone) or metal (e.g.,aluminum, titanium, stainless steel, or the like). In some embodiments,the housing 14 and/or the sleeve 12 are constructed of materials thatare translucent, opaque, or otherwise optically distortive, such thatsome portion (such as the tip) or all of the needle 16 is not generallyvisible to the patient in a typical injection and/or aspirationprocedure before, during, and/or after the injection and/or aspirationitself. Furthermore, aside from the channel 26 and the openings 48 inthe housing 14 for the axial locking member 50, certain examples of thehousing 14 and sleeve 12 are generally or entirely enclosed, e.g.,devoid of slots, openings, or other apertures to inhibit a patient fromviewing the needle 16. Thus, during an injection and/or aspirationprocedure, any portion of the needle 16 that does not extend through thechannel 26 can be obscured from view by the housing 14 and sleeve 12,and any portion of the needle 16 that extends through the channel 16will be obscured from view because it is inside a vial or inside thepatient. Of course, in some instances the entire needle 16 may not befully obscured from view throughout the injection and/or aspirationprocedure depending upon, among other things, the specific shapes of thedistal end 62 of the sleeve 12, and the angle at which the needle 16 isinserted into the vial and/or the patient's skin or tissue. Because manypeople become anxious simply at the sight of a needle, theabove-described features can significantly reduce the anxiety or fear ofthe patient and/or the person administering the injection and/oraspiration (who may also be the patient in cases of self-injection) toprovide a more comfortable overall treatment experience.

In some embodiments, the distal end 62 of the sleeve 12 provides apressure-receptor stimulation feature. Stimulation of thepressure-receptor nerves in the area of an injection and/or aspirationhas been found to compete or interfere with stimulation of the painreceptor nerves. In many patients, stimulation of the pressure-receptornerves in this manner reduces the perception of pain during insertion ofthe needle 16. Accordingly, in some constructions the distal end 62includes a plurality of axially and/or radially extending ribs orprojections 130 extending from the distal end 62 and away from thechannel 26. For example, in some embodiments the ribs or projections arearranged generally in the shape of an asterisk centered about theaperture 28. During use, the projections 130 can be configured to engagethe skin or tissue of a patient just prior to the tip 46 of the needle16 coming into contact with the skin or tissue of the patient. In thisway, the projections 130 apply pressure to the skin or tissue thatstimulates the patient's pressure-receptor nerves prior to or at aboutthe same time as insertion of the needle 16. In some embodiments, thedistal end 62 comprises one or a series of depressions or protrusions,such as bumps, cones, rings, or the like, for engaging the skin ortissue of the patient and stimulating the patient's pressure-receptorsprior to insertion of the needle 16. Some arrangements, the distal end62 of the sleeve 12 is substantially flat, beveled, or the like. Thespecific configuration of the distal end 62 generally will varydepending upon, among other things, the intended field of use for thecover 10.

Some arrangements of the cover 10 include a therapeutic substancepositioned at the distal end 62. For instance, in some embodiments thedistal end 62 includes a topical anesthetic. In some embodiments, thedistal end 62 includes an antiseptic, such as iodine or rubbing alcohol,and/or an antibiotic or antiviral medication. In some embodiments thetherapeutic substance is applied or protected by a cap until the cover10 is to be used.

In certain embodiments, aside from the bias of the spring 70, the sleeve12 retracts substantially without impediment. The cover 10 need notrequire a first hand to provide pressure and/or operate the plunger onthe syringe and a second hand to operate another feature (e.g., aclasp). In some embodiments, movement of the sleeve 12 automaticallyengages one or more of the locking members 50, 110. In some embodiments,movement of the sleeve 12 from an about fully retracted position to anabout fully extended position automatically prevents or inhibits reuseof the cover 10. The cover 10 can be configured to facilitate one-handedretraction of the sleeve 12 (exposure needle 16), one-handed operationof the syringe, one-handed retraction of the sleeve 12 (covering of theneedle 16), and/or one-handed engagement of features to inhibit reuse ofthe cover 10. Aside from retracting and/or extending the sleeve 12, thecover 10 can lock automatically and need not require external input(e.g. from manual manipulation of the user's fingers) to engage theaxial locking member 50 and/or the rotational locking member 110.

In some embodiments, the cover 10 is manufactured by forming the housing14 with the needle support portion 30, the distal opening 42, and theguide member 44. In embodiments in which housing 14 comprises multiplepieces, the manufacturing process can include the step of assembling thehousing 14. A sleeve is formed that has the tracks 80-84. The guidemember 44 is aligned with the insertion portion 86 of the first track80. The sleeve 12 is slidingly moved through the distal opening 42. Insome variants the guide member 44 moves up the incline in the insertionportion 86 and snaps into the first track 80 at about the flat face 88,thus preventing the guide member 44 from returning to the insertionportion 86. The needle 16 is coupled with the needle support portion 30of the housing 14. The spring 16 is inserted into the central chamber 36of the housing 14 and positioned to bias the sleeve 12.

As shown in FIGS. 1C and 1D, the cover 10 can include a cap 32 that isremovably coupled to the housing 14. A distal end of the cap 32 can movebetween an open position (FIG. 1C) and a closed position (FIG. 1D) byway of a hinge 33. In the closed position, the cap 32 reduces orprevents contamination of the sleeve 12 and distal end 38 of the housing14, for example during shipping and storage of the cover 10. The cap 32is generally kept in the closed position until just prior to aninjection and/or aspiration procedure, at which time the cap 32 is movedto the open position and/or removed from the housing 14. In someembodiments, opening or removing the cap 32 before an injection and/oraspiration procedure does not expose the needle 16 because the sleeve 12covers the needle 16, as shown in FIGS. 1 and 1A. Furthermore, if thecap 32 is removed, it may immediately be discarded because the sleeve 12also covers the needle 16 once the injection and/or aspiration procedureis completed. The cap 32 can include an open portion 37 configured to,for example, facilitate opening and closing the cap 32.

In some embodiments, the cap can include a moveable or removable portionto assist in properly drawing a dose from a vial. For example, the cap32 can be sized and configured to prevent the sleeve 12 from beingretracted into the housing 14 a sufficient distance that the guidemember 44 would enter the second track 82 or the transfer track 84. Insome embodiments, the cap 32 is configured to prevent the sleeve 12 fromretracting into the housing 14 far enough to engage the axial lockingmember 50 and/or rotational locking member 110, which may otherwiseprevent further use of the device. In some embodiments, the cap 32limits the retraction of the sleeve 12 such that the guide member 44remains slidingly received in the first track 80.

To reduce anxiety, particularly in children, the cap 32, the housing 14,and/or the sleeve 12 may be provided with a variety of aesthetic designssuch as rainbows, balloons, cartoon characters, or other illustrationsthat are generally considered pleasing and comforting to children. Inthis way, a child patient may be allowed to choose from a variety ofdifferent covers 10 prior to an injection and/or aspiration procedure.The cap 32, in addition or as an alternative to being colored or bearingindicia, may be fabricated to resemble a variety of different cartooncharacters or other objects such that, upon removal from the housing 14prior to an injection and/or aspiration procedure, the cap 32 may bepresented to a child patient as a distraction during the injectionand/or aspiration procedure. When fabricated to resemble a cartooncharacter or other object, the size and generally cylindrical shape ofthe cap 32 make it particularly well suited for use by the child as afinger puppet. Each of these features provides the opportunity to reducethe anxiety or fear experienced by many children before, during, andafter an injection and/or aspiration procedure.

FIGS. 1-8A illustrate the cover 10 in various positions during anoperating cycle that proceeds from the initial or ready-for-use extendedconfiguration shown in FIG. 1, to an intermediate or a fully retractedposition shown in FIG. 5, and to a final or reuse-prevention, extendedconfiguration shown in FIG. 8A. It should be understood that thefollowing presents an exemplary embodiment and is not intended to belimiting. It should be further understood that, although this embodimentdescribes the needle 16 being used to penetrate a patient's skin, thecover 10 is not limited to such use.

FIGS. 1-1C illustrate the cover 10 in the initial, ready-to-useconfiguration. As discussed above, the cover 10 is coupled to a syringeor other medical device, thus placing the syringe in fluid communicationwith the needle 16. After removing the cap 32 (if used) and takingsurface prepatory steps (if appropriate, e.g. applying a disinfectant tothe surface), the distal end 62 of the cover 10 can be placed againstthe patient's skin at the desired penetration site.

Referring now to FIG. 2, the cover 10 is illustrated in a firstpartially retracted configuration. Retraction of the sleeve 12 isgenerally initiated by a user applying pressure on the cover 10 and/orsyringe in the distal direction, which thereby encourages the sleeve 12proximally against the bias of the spring 70. This retraction of thesleeve 12 in turn exposes the distal tip 96 of the needle 16 andinitiates penetration by the needle 16 into the patient's skin. Theguide member 44 of the housing 14, which is positioned in the firsttrack 80, directs the sleeve 12 to move axially until about theintersection of the first and transfer tracks 80, 84. Upon reaching theintersection of the first and transfer tracks 80, 84 the guide member 44seats against the flat face 88, which directs the guide member into thetransfer track 84. At this stage of the operation, the process may bereversed. If the distal pressure is removed, then the cover 10 canreturn to the original ready-for-use configuration shown in FIG. 1. Asshown in FIGS. 2A and 2B, as the flange 64 of the sleeve 12 movesproximally, the axial locking member 50 passes through the notch 116 inthe flange 64.

In the illustrated configuration of FIG. 3, the sleeve 12 has movedfurther proximally and the needle 16 has been further exposed. At thispoint, the sleeve 12 has moved sufficiently proximally that the proximalportion 90 of the channel 26 has started to receive the needle supportportion 30, the axial locking member 50 has passed through the notches116 in the flange 64 (FIG. 3A), and the guide member 44 is positioned inthe transfer track 84. As the sleeve 12 moves proximally, the guidemember 44 passes through the transfer track 84 thereby encouraging thesleeve 12 to rotate about the axis 18 approximately the number ofdegrees, e.g. at least about 5° and/or less than or equal to about 90°,that separate the first and second tracks 80, 82. Rotation of the sleeve12 in turn rotates the flange 64, including the impeding member 102. Asshown in FIG. 3B, the inclined face 106 of the impeding member 102rotates toward the inclined face 112 of the rotational locking member110. Continued rotation of the impeding member 102 of the flange 64 ofthe sleeve 12 slidably engages the inclined faces 106, 112, therebydeflecting the impeding member 102 radially inward and producing aslight but noticeable resistance. In some embodiments, as illustrated,the length of the impeding member 102 can be generally about the samesize as or shorter than the length of the transfer track 84.

Turning to the illustrations of FIGS. 4 and 4A, the sleeve 12 hascontinued to retract into the housing 14, which has further exposed theneedle 16. The guide member 44 has shifted from the transfer track 84 tothe second track 82, thus further rotating the sleeve 12 with respect tothe housing 14. The needle support portion 30 has been further receivedby the proximal portion 90 of the channel 26. As shown in FIG. 4B, oncethe inclined face 106 of the impeding member 102 rotated beyond thezenith of the inclined face 112 of the rotational locking member 110,the impeding member 102 deflected radially outward, thus returning toabout its radial position shown in FIG. 2B. In this configuration, thegenerally flat faces 108, 114 present a physical stop thereby inhibitingcounter-rotation of the sleeve 12. This in turn prevents the guidemember 44 from returning into the transfer track 84, as will bediscussed below. In some embodiments, the outward deflection of theimpeding member 102 produces a tactile vibration and/or an audiblesound, e.g. “snap,” which can provide verification that the rotationallocking member 110 has been locked and counter-rotation is prevented.

The fully retracted configuration of the cover 10 is illustrated in FIG.5. The needle 16 is at its apex of exposure, presenting the longestexposed needle length. The distal end 62 of sleeve 12 is generally flushwith distal end 38 of housing 12. The proximal portion 90 of the channel26 has approximately fully received the needle support portion 30. Thespring 70 is compressed to generally its fully compressed configuration.In several embodiments, this is the configuration in which the syringe'scontents are injected, via the hub 20 and needle 16, into the patient.

Turning to FIGS. 6 and 6A, an initial stage of withdrawal of the needle16 is shown. Withdraw generally initiates when the user pulls away thesyringe from the patient, or when the user applies less distal pressureon the cover 10 and/or syringe, thus permitting the bias of the spring70 to distally extend the sleeve 12. As the sleeve 12 distally extendsit receives the needle 16 into the channel 26 thereby covering at leasta portion (such as the distal end) of the needle 16. The distal movementof the sleeve 12 also slides the guide member 44 along the second track82. The engagement of the generally flat faces 108, 114 inhibits orprevents counter-rotation of the sleeve 12, which in turn prevents theguide member 44 from shifting into the transfer track 84 at intersectionbetween the second track 82 and the transfer track 84.

FIGS. 7 and 7A illustrate a configuration of the cover 10 in which thesleeve 12 has been further extended and the needle 16 has been furthercovered. At this stage in the operation, as the sleeve 12 movesdistally, the outwardly extending portion 100 of the flange 64 slidinglyengages the axial locking member 50. The outwardly extending portion 100of flange 64 encourages the axial locking member 50 radially outward andproduces a slight but noticeable resistance.

Moving now to FIGS. 8 and 8A, an extended, reuse-prevention,configuration of the cover 10 is depicted. The sleeve 12 has been fullyextended and fully covers the needle 16. The spring 70 has moved thesleeve 12 distally until the flange 64 seated against the shoulder 40.Upon the outwardly extending portion 100 of the flange 64 moving distalof the second end 54 of the axial locking member 50, the axial lockingmember 50 snapped radially inward with respect to the outwardlyextending portion 100 of the flange 64. The axial locking member 50 thuspresents a physical stop to inhibit the sleeve 12 from being proximallyretracted again. In some embodiments, the inward deflection of the leastone axial locking member 50 produces a tactile vibration and/or anaudible sound, e.g. “snap,” which can provide verification that theaxial locking member 50 has been engaged.

FIGS. 9-14A illustrate another embodiment of the cover 10. Severalfeatures and components of the cover 10 a are similar in form andfunction to those described above with respect to the cover 10, and havebeen provided with like numerals. To the extent components of the cover10 a differ slightly from those of the cover 10 described above, somethose differences are described and explained below. Any features and/orcomponents of the disclosed embodiments can be combined or usedinterchangeably.

In the embodiment illustrated in FIGS. 9-9B, the cover 10 a includes agenerally cylindrical housing 14 a that comprises an axis 18 a, alongwhich a needle 16 a is positioned. A distal end of the housing 14 acouples to a sleeve 12 a configured to translate along and at leastpartially rotate about the axis 18 a. A proximal end 60 a of the sleeve12 a couples to a radially outwardly extending flange 64 a. A proximalend 34 a of the housing 14 a comprises or is coupled to a hub 20 a. Aninside surface 22 a of the housing 14 a includes a central chamber 36 a.One or more ribs 110 a extend radially inwardly from the inner surface22 a. A distal end 38 a of the housing 14 a includes a radially inwardlyextending shoulder 40 a that includes an opening 42 a that communicateswith the chamber 36 a. The opening 42 a slidingly receives the sleeve 12a that in turn receives and covers the needle 16 a. A guide member 44 aextends radially inwardly from the shoulder 40 a and is configured toengage one or more tracks formed in the sleeve 12 a.

With continued reference the illustrations of FIGS. 9-9B, the housing 14a includes at least one axial locking member 50 a. The axial lockingmember 50 a can extend generally parallel to the axis 18 a from theinner surface 22 a of the proximal end 34 a of the housing 14 a to nearthe inner surface 22 a of the distal end 38 a of the housing 14 a. Aportion of the axial locking member 50 a extends about parallel to theaxis 18 a and is configured to avoid interference with a flange 64 a ofthe sleeve 12 a as the sleeve 12 a moves axially. A second end 54 a ofthe axial locking member 50 a angles radially inward. As shown in FIG.9B, in some arrangements the second end 54 a of the axial locking member50 a aligned with a notch 116 a in a flange 64 a, thereby permitting thesecond end 54 a to pass though the notch 116 a.

Referring to FIGS. 10-10B, the cover 10 a is shown in a partiallyretracted configuration. As discussed above, the guide member 44 atravels proximally a distance along a first track 80 a during retractionof the sleeve 12 a. The guide member 44 a can be directed into atransfer track 84 a intersecting the first track 80 a and in turndirected into a second track 82 a, thereby at least partially rotatingthe sleeve 12 a with respect to the housing 14 a. The transfer track 84a can be inclined, such that a height difference exists between thetransfer track 84 a and the second track 82 a. The incline in thetransfer track 84 a can produce a slight but noticeable resistance. Theguide member 44 a can be directed across the height difference and intothe second track 82 a, and can thereby produce an audible or tactilealert. The height difference can prevent or inhibit the guide member 44a from returning into the transfer track 84 a and, in turn, inhibitrotation of the sleeve 12. In the arrangement shown, as the sleeve 12 arotates, an outwardly extending portion 100 a of a flange 64 a rotatesinto radial interference with the second end 54 a.

FIGS. 11 and 11A depict the cover 10 a in a configuration with thesleeve 12 a fully retracted. The guide member 44 a has been directedinto and traveled a distance along the second track 82 a. As shown, adistal end 62 a of the sleeve 12 a is generally flush with a distal end38 a of the housing 14 a.

Configurations of the cover 10 with the sleeve 12 a in progressivelyextended positions are shown in FIGS. 12-14A. As the bias of the spring70 a encourages the sleeve 12 a distally, the guide member 44 a in thesecond track 82 a prevents or inhibits rotation of the sleeve 12 a withrespect to the housing 14 a. As stated above, a height differencebetween the second track 82 a and the transfer track 84 a can prevent orinhibit the guide member 44 a from moving from the second track 82 a tothe transfer track 84 a. As the flange 64 a nears the distal end 38 a ofthe housing, the outwardly extending portion 100 a encourages the axiallocking member 50 a radially outward, thereby producing a slight butnoticeable resistance. Once the flange 64 a has moved distal of thesecond end 54 a of the axial locking member 50 a, the locking member 50a returns radially inwardly to its position prior to engagement with theflange 64 a. In several embodiments, such movement of the at axiallocking member 50 a produces a tactile or audible alert. As shown inFIG. 14A, the second end 54 a of the at least one axial locking member50 a prevents the outwardly extending portion 100 a of the flange 64 afrom moving proximally. Reuse of the cover 10 a is therefore inhibitedor prevented.

Although the needle cover has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the needle cover extends beyond the specificallydisclosed embodiments to other alternative embodiments and/or uses ofthe invention and obvious modifications and equivalents thereof. Forexample, the locking and/or reuse inhibiting features could be used in avariety of medical and non-medical fields. For example, although theembodiments of the sleeve and housing described above are generallycircular in axial cross-sectional shape, other embodiments of the sleeveand housing employ various other shapes, such as square, elliptical,hexagonal, octagonal, or the like. It should be understood that variousfeatures and aspects of the disclosed embodiment can be combined with orsubstituted for one another in order to form varying modes of the needlecover. For example, in some embodiments the plurality of tracks arepositioned on the inner surface of the housing and are configured toreceive the guide member, which extends outwardly from the sleeve. Thus,it is intended that the scope of the needle cover herein-disclosedshould not be limited by the particular disclosed embodiments describedabove, but should be determined only by a fair reading of the claimsthat follow.

The following is claimed:
 1. A locking needle cover, comprising: aneedle having a longitudinal axis and a distal tip; a housing attachedwith the needle, the housing configured to couple with a medicalimplement such that the medical implement and the distal tip of theneedle are in fluid communication; a sleeve having a flange with acircumferential notch and at least a portion received in the housing,the sleeve configured to rotate about and translate proximally along thelongitudinal axis from an initial position to a retracted position, thesleeve also configured to translate distally along the longitudinal axisfrom the retracted position to a locked position, a greater longitudinallength of the sleeve being received in the housing in the retractedposition than in the initial position; indicia positioned along thesleeve, the indicia configured to indicate a longitudinal distancebetween a distal end of the sleeve and the distal tip of the needle,thereby providing an indication of the insertion depth of the distal tipof the needle into a body; and a locking member configured to passthrough the circumferential notch in the flange in the sleeve when thesleeve is moved from the initial position to the retracted position, thelocking member configured to engage with and be radially outwardlydeflected by the flange in the sleeve when the sleeve is moved from theretracted position to the locked position, the locking member configuredto inhibit proximal movement of the sleeve when the sleeve is in thelocked position.
 2. The cover of claim 1, wherein the indicia comprise ascale printed on the sleeve.
 3. The cover of claim 1, wherein thelocking member comprises a radially inwardly extending arm.
 4. The coverof claim 1, wherein, in the initial position, at least some of thesleeve extends distally beyond the distal tip of the needle.
 5. Thecover of claim 1, wherein at least some of the sleeve extends distallybeyond the distal tip of the needle when the sleeve is in the lockedposition.
 6. The cover of claim 1, further comprising: a guide memberpositioned on one of the housing and the sleeve; and a plurality oftracks positioned on the other of the housing and the sleeve, theplurality of tracks configured to receive the guide member; wherein theguide member moves along at least one of the plurality of tracks as thesleeve rotates about and translates along the longitudinal axis from theinitial position to the retracted position.
 7. The cover of claim 1,wherein the medical implement is a syringe.
 8. The cover of claim 1,further comprising a cap configured to inhibit the sleeve from movingproximally beyond an intermediate position that is located between theinitial position and the retracted position, wherein the locking memberis not engaged until the sleeve is moved proximally beyond theintermediate position.
 9. A method of providing an injection to apatient, the method comprising: joining a passive locking needle coverand a medical implement to form an injection assembly, the needle covercomprising: a needle having a longitudinal axis and a distal tip; ahousing connected with the needle; a sleeve having at least a portionreceived in the housing, the sleeve including a circumferential notch,the sleeve configured to rotate about and translate along thelongitudinal axis; a scale positioned along the sleeve and configured toindicate an insertion depth of the distal tip of the needle; and a firstlocking member; positioning a distal end of the needle cover adjacent adesired injection surface; applying a distal force to the injectionassembly such that the distal end of needle cover is pressed against theinjection surface, the sleeve is moved from an extended position towarda retracted position, and the needle penetrates the injection surface;passing the first locking member through the circumferential notch ofthe sleeve when the sleeve is moved from the extended position to theretracted position; moving the sleeve relative to the housing such thata second locking member of the needle cover radially deflects animpeding member of the needle cover from a rest position to a deflectedposition; observing, with the scale, the insertion depth of the distaltip of the needle into the injection surface; reducing the amount ofdistal force applied to the injection assembly such that a biasingmember moves the sleeve distally until a portion of the sleeve ispositioned distal of the distal end of the needle; allowing the impedingmember to return to the rest position, thereby inhibitingcounter-rotation of the sleeve due to an interference between the secondlocking member and the impeding member; and automatically engaging thefirst locking member such that subsequent movement of the sleeve towardthe retracted position is inhibited, thereby protecting againstunintentional needle sticks and preventing reuse of the needle cover.10. The method of claim 9, further comprising deflecting the lockingmember radially outward with a flange of the sleeve.
 11. The method ofclaim 9, further comprising obscuring the needle from the view of thepatient at least during and after the injection, thereby reducing oralleviating anxiety that could result from the patient viewing theneedle.
 12. The method of claim 9, wherein the entire needle isprotected by the needle cover after the injection.
 13. The method ofclaim 9, further comprising deflecting the locking member with thesleeve during distal movement of the sleeve.
 14. The method of claim 9,wherein the sleeve further comprises a flange, the circumferential notchbeing positioned in the flange.